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ID

40447

Description

Cardioprotective and Metabolic Effects of Metformin in Patients With Heart Failure and Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01690091

Link

https://clinicaltrials.gov/show/NCT01690091

Keywords

Versions (2)
  1. 4/21/20 4/21/20 -
  2. 4/21/20 4/21/20 -
Copyright Holder

See clinicaltrials.gov

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April 21, 2020

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License

Creative Commons BY 4.0
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    Eligibility Insulin Resistance NCT01690091

    English

    Eligibility Insulin Resistance NCT01690091

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. chronic heart failure will be defined by the following criteria (all must be included):
    Description

    Chronic heart failure | Inclusion criteria All Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0264716
    UMLS CUI [2,1]
    C1512693
    UMLS CUI [2,2]
    C0444868
    UMLS CUI [2,3]
    C1550543
    diagnosis of hf known for at least 6 months
    Description

    Heart failure Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0449238
    medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - x-ray findings or swelling of lower extremities
    Description

    Medical History Hospitalization Heart Decompensation | Patient need for Parenteral therapy Congestion | X-ray of both lower extremities | Edema of lower extremity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0019993
    UMLS CUI [1,3]
    C1961112
    UMLS CUI [2,1]
    C0686904
    UMLS CUI [2,2]
    C0259961
    UMLS CUI [2,3]
    C0700148
    UMLS CUI [3]
    C3861120
    UMLS CUI [4]
    C0239340
    stable drug therapy at least 1 month
    Description

    Pharmacotherapy Stable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0205360
    treatment with diuretics (thiazide or furosemide)
    Description

    Diuretics | Thiazide | Furosemide

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0012798
    UMLS CUI [2]
    C0012802
    UMLS CUI [3]
    C0016860
    lvef below 50%
    Description

    Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    2. the presence of diabetes will be defined by:
    Description

    Diabetes Mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011849
    diagnosis and treatment of type 2 diabetes in the medical history
    Description

    Medical History Non-Insulin-Dependent Diabetes Mellitus | Therapy Non-Insulin-Dependent Diabetes Mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0011860
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0011860
    screening blood sample:
    Description

    Blood specimen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0178913
    the value of hba1c(according to ifcc)≥ 4.8% + fasting glucose ≥ 7.0 mmol /
    Description

    Hemoglobin A1c measurement | Fasting glucose measurement Venous plasma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    UMLS CUI [2,1]
    C0202045
    UMLS CUI [2,2]
    C3838734
    l in venous plasma or
    Description

    ID.11

    Data type

    boolean

    the value of hba1c ≥ 4.8%(according to ifcc) + random blood glucose ≥ 11.1 mmol/l in venous plasma
    Description

    Hemoglobin A1c measurement | Random blood glucose measurement Venous plasma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    UMLS CUI [2,1]
    C0428567
    UMLS CUI [2,2]
    C3838734
    or ogtt - blood glucose level at 120 min ≥ 11.1 mmol/l ogtt is indicated just in case of positivity of one of the criteria (fasting glucose + hba1c or hba1c + random blood glucose)
    Description

    Oral Glucose Tolerance Test | Blood glucose measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029161
    UMLS CUI [2]
    C0392201
    treatment of diabetes - by diet only
    Description

    Diet therapy Diabetes Mellitus

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012159
    UMLS CUI [1,2]
    C0011849
    women and men aged 40-70 years
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    body mass index (kg/m2) in the range of 20-35
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    the range of hba1c between 4-6,5% ifcc
    Description

    Hemoglobin A1c measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0474680
    signed informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. the planned cardiac intervention during the study that affect the function of the heart (revascularization including pci, heart surgery, implantation of pacemaker, rf ablation; urgent candidate for ots
    Description

    Intervention cardiac Affecting Cardiac function | Revascularization | Percutaneous Coronary Intervention | Cardiac Surgery procedures | Implantation of cardiac pacemaker | Radiofrequency ablation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0184661
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [1,3]
    C0392760
    UMLS CUI [1,4]
    C0232164
    UMLS CUI [2]
    C0581603
    UMLS CUI [3]
    C1532338
    UMLS CUI [4]
    C0018821
    UMLS CUI [5]
    C0189842
    UMLS CUI [6]
    C0850292
    2. metabolic disease, including: 1 type diabetes, decompensated thyreopathy (note: patients with hypothyroidism and stable substitution (the last 3 months) of normal tsh levels may participate in the study
    Description

    Metabolic Disease | Diabetes Mellitus, Insulin-Dependent | Thyroid Disease Decompensated

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0025517
    UMLS CUI [2]
    C0011854
    UMLS CUI [3,1]
    C0040128
    UMLS CUI [3,2]
    C0205434
    3. treatment with insulin or pad one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study)
    Description

    Insulin regime Recent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0557978
    UMLS CUI [1,2]
    C0332185
    4. pregnancy (positive β-hcg test), breast feeding, trying to become pregnant
    Description

    Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding | Trying to conceive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C0430060
    UMLS CUI [2,2]
    C1514241
    UMLS CUI [3]
    C0006147
    UMLS CUI [4]
    C0420843
    5. clinically significant anemia with hemoglobin below 100 g/l
    Description

    Anemia | Hemoglobin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002871
    UMLS CUI [2]
    C0518015
    6. renal insufficiency with egf below 0.7 ml/s
    Description

    Renal Insufficiency | Estimated Glomerular Filtration Rate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C3811844
    7. atrial fibrillation - present during screening test
    Description

    Atrial Fibrillation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004238
    8. the presence of other medical condition, which occurs during physical examination, laboratory tests, ecg, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
    Description

    Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Electrocardiography | Lung disease | Nervous system disorder | Inflammatory disorder

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0681873
    UMLS CUI [2]
    C0031809
    UMLS CUI [3]
    C0022885
    UMLS CUI [4]
    C1623258
    UMLS CUI [5]
    C0024115
    UMLS CUI [6]
    C0027765
    UMLS CUI [7]
    C1290884
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    Similar models

    Eligibility Insulin Resistance NCT01690091

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic heart failure | Inclusion criteria All Fulfill
    Item
    1. chronic heart failure will be defined by the following criteria (all must be included):
    boolean
    C0264716 (UMLS CUI [1])
    C1512693 (UMLS CUI [2,1])
    C0444868 (UMLS CUI [2,2])
    C1550543 (UMLS CUI [2,3])
    Heart failure Duration
    Item
    diagnosis of hf known for at least 6 months
    boolean
    C0018801 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Medical History Hospitalization Heart Decompensation | Patient need for Parenteral therapy Congestion | X-ray of both lower extremities | Edema of lower extremity
    Item
    medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - x-ray findings or swelling of lower extremities
    boolean
    C0262926 (UMLS CUI [1,1])
    C0019993 (UMLS CUI [1,2])
    C1961112 (UMLS CUI [1,3])
    C0686904 (UMLS CUI [2,1])
    C0259961 (UMLS CUI [2,2])
    C0700148 (UMLS CUI [2,3])
    C3861120 (UMLS CUI [3])
    C0239340 (UMLS CUI [4])
    Pharmacotherapy Stable
    Item
    stable drug therapy at least 1 month
    boolean
    C0013216 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    Diuretics | Thiazide | Furosemide
    Item
    treatment with diuretics (thiazide or furosemide)
    boolean
    C0012798 (UMLS CUI [1])
    C0012802 (UMLS CUI [2])
    C0016860 (UMLS CUI [3])
    Left ventricular ejection fraction
    Item
    lvef below 50%
    boolean
    C0428772 (UMLS CUI [1])
    Diabetes Mellitus
    Item
    2. the presence of diabetes will be defined by:
    boolean
    C0011849 (UMLS CUI [1])
    Medical History Non-Insulin-Dependent Diabetes Mellitus | Therapy Non-Insulin-Dependent Diabetes Mellitus
    Item
    diagnosis and treatment of type 2 diabetes in the medical history
    boolean
    C0262926 (UMLS CUI [1,1])
    C0011860 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0011860 (UMLS CUI [2,2])
    Blood specimen
    Item
    screening blood sample:
    boolean
    C0178913 (UMLS CUI [1])
    Hemoglobin A1c measurement | Fasting glucose measurement Venous plasma
    Item
    the value of hba1c(according to ifcc)≥ 4.8% + fasting glucose ≥ 7.0 mmol /
    boolean
    C0474680 (UMLS CUI [1])
    C0202045 (UMLS CUI [2,1])
    C3838734 (UMLS CUI [2,2])
    ID.11
    Item
    l in venous plasma or
    boolean
    Hemoglobin A1c measurement | Random blood glucose measurement Venous plasma
    Item
    the value of hba1c ≥ 4.8%(according to ifcc) + random blood glucose ≥ 11.1 mmol/l in venous plasma
    boolean
    C0474680 (UMLS CUI [1])
    C0428567 (UMLS CUI [2,1])
    C3838734 (UMLS CUI [2,2])
    Oral Glucose Tolerance Test | Blood glucose measurement
    Item
    or ogtt - blood glucose level at 120 min ≥ 11.1 mmol/l ogtt is indicated just in case of positivity of one of the criteria (fasting glucose + hba1c or hba1c + random blood glucose)
    boolean
    C0029161 (UMLS CUI [1])
    C0392201 (UMLS CUI [2])
    Diet therapy Diabetes Mellitus
    Item
    treatment of diabetes - by diet only
    boolean
    C0012159 (UMLS CUI [1,1])
    C0011849 (UMLS CUI [1,2])
    Age
    Item
    women and men aged 40-70 years
    boolean
    C0001779 (UMLS CUI [1])
    Body mass index
    Item
    body mass index (kg/m2) in the range of 20-35
    boolean
    C1305855 (UMLS CUI [1])
    Hemoglobin A1c measurement
    Item
    the range of hba1c between 4-6,5% ifcc
    boolean
    C0474680 (UMLS CUI [1])
    Informed Consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Intervention cardiac Affecting Cardiac function | Revascularization | Percutaneous Coronary Intervention | Cardiac Surgery procedures | Implantation of cardiac pacemaker | Radiofrequency ablation
    Item
    1. the planned cardiac intervention during the study that affect the function of the heart (revascularization including pci, heart surgery, implantation of pacemaker, rf ablation; urgent candidate for ots
    boolean
    C0184661 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C0392760 (UMLS CUI [1,3])
    C0232164 (UMLS CUI [1,4])
    C0581603 (UMLS CUI [2])
    C1532338 (UMLS CUI [3])
    C0018821 (UMLS CUI [4])
    C0189842 (UMLS CUI [5])
    C0850292 (UMLS CUI [6])
    Metabolic Disease | Diabetes Mellitus, Insulin-Dependent | Thyroid Disease Decompensated
    Item
    2. metabolic disease, including: 1 type diabetes, decompensated thyreopathy (note: patients with hypothyroidism and stable substitution (the last 3 months) of normal tsh levels may participate in the study
    boolean
    C0025517 (UMLS CUI [1])
    C0011854 (UMLS CUI [2])
    C0040128 (UMLS CUI [3,1])
    C0205434 (UMLS CUI [3,2])
    Insulin regime Recent
    Item
    3. treatment with insulin or pad one month before the recruitment(patients who were temporarily treated with insulin during hospitalization may participate in the study)
    boolean
    C0557978 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding | Trying to conceive
    Item
    4. pregnancy (positive β-hcg test), breast feeding, trying to become pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0430060 (UMLS CUI [2,1])
    C1514241 (UMLS CUI [2,2])
    C0006147 (UMLS CUI [3])
    C0420843 (UMLS CUI [4])
    Anemia | Hemoglobin measurement
    Item
    5. clinically significant anemia with hemoglobin below 100 g/l
    boolean
    C0002871 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    Renal Insufficiency | Estimated Glomerular Filtration Rate
    Item
    6. renal insufficiency with egf below 0.7 ml/s
    boolean
    C1565489 (UMLS CUI [1])
    C3811844 (UMLS CUI [2])
    Atrial Fibrillation
    Item
    7. atrial fibrillation - present during screening test
    boolean
    C0004238 (UMLS CUI [1])
    Other medical condition Interferes with Research data | Physical Examination | Laboratory Procedures | Electrocardiography | Lung disease | Nervous system disorder | Inflammatory disorder
    Item
    8. the presence of other medical condition, which occurs during physical examination, laboratory tests, ecg, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data
    boolean
    C3843040 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0681873 (UMLS CUI [1,3])
    C0031809 (UMLS CUI [2])
    C0022885 (UMLS CUI [3])
    C1623258 (UMLS CUI [4])
    C0024115 (UMLS CUI [5])
    C0027765 (UMLS CUI [6])
    C1290884 (UMLS CUI [7])
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